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Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05226871
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

The purpose of this clinical trial is to provide study medicine(s) and learn about their safety. This study is seeking participants who:

  • Have benefited from ongoing study treatment as determined by the study doctor in a Pfizer-sponsored palbociclib Parent Study
  • Must agree to follow the reproductive criteria
  • Are willing and able to comply with all scheduled visits, treatment plans, and other study procedures
  • Can give signed informed consent documents

Participants in this study will continue to receive treatment as they were in the parent study. The time by which participants will take part in this study is retrospective (after completed parent study). We will examine the experiences of people receiving the study medicine(s). This will help us determine if the study medicine(s) are safe. During this time, the participants will be monitored for the safety of the study medicine(s).


Condition or disease Intervention/treatment Phase
Breast Cancer Head and Neck Cancer Drug: Palbociclib Drug: Cetuximab Drug: Fulvestrant Drug: Letrozole Phase 2

Detailed Description:
This is an open-label study to provide continued access to treatment for eligible participants who continue to derive clinical benefit as determined by the investigator from study intervention(s) in a Pfizer-sponsored palbociclib clinical study (Parent Study)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : April 19, 2026
Estimated Study Completion Date : April 19, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arms and Interventions
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Arm Intervention/treatment
Arm 1
Cetuximab
 Drug: Cetuximab
Intravenous (IV) infusion
Experimental: Arm 2
Palbociclib plus Cetuximab
 Drug: Palbociclib
oral
Other Name: IBRANCE

Drug: Cetuximab
Intravenous (IV) infusion
Arm 3
Palbociclib plus Fulvestrant
 Drug: Palbociclib
oral
Other Name: IBRANCE

Drug: Fulvestrant
Intramuscular (IM)
Arm 4
Palbociclib plus Letrozole
 Drug: Palbociclib
oral
Other Name: IBRANCE

Drug: Letrozole
oral


Outcome Measures
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Primary Outcome Measures :
  1. Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 28 days after last dose of study intervention ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any participant who is receiving study treatment and deriving clinical benefit as determined by the investigator in a Pfizer-sponsored palbociclib Parent Study
  • Participants must agree to follow the reproductive criteria
  • Participants who are willing and able to comply with all scheduled visits, treatment plans, and other study procedures
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document and protocol

Exclusion Criteria:

  • Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05226871


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06351
Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Recruiting
Monterrey, Nuevo LEÓN, Mexico, 64460
Ukraine
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" Recruiting
Chernivtsi, Chernivetska Oblast, Ukraine, 58013
Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council Recruiting
Ivano-Frankivsk, Ukraine, 76000
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05226871    
Other Study ID Numbers: A5481173
2021-005735-22 ( EudraCT Number )
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Hormone Receptor Positive Advanced Breast Cancer
Squamous Cell Carcinoma of the Head and Neck
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Letrozole
Fulvestrant
Palbociclib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Protein Kinase Inhibitors